Alpha1-Proteinase Inhibitors – Commercial Medical Benefit Drug Policyopen_in_new

This policy covers intravenous alpha1‑proteinase inhibitor augmentation and maintenance therapy (Aralast NP™, Glassia™, Prolastin®‑C, Zemaira®) for emphysema due to congenital alpha1‑antitrypsin (AAT) deficiency. Coverage is limited to patients with AAT deficiency confirmed by specified genotypes or disease‑causing alleles and serum AAT <11 µmol/L, with emphysema confirmed by pulmonary function testing, who are current nonsmokers receiving optimal conventional therapy; dosing must follow FDA labeling, initial authorization is up to 12 months, and continuation requires documented clinical benefit and ongoing eligibility.

"Documentation of diagnosis of congenital alpha1-antitrypsin deficiency confirmed by genotype/phenotype: Pi*ZZ, Pi*Z(null), Pi*(null)(null) protein phenotypes (homozygous) or other disease-causing a..."

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